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Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy

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ClinicalTrials.gov Identifier: NCT01760616
Recruitment Status : Unknown
Verified April 2016 by Qidong Gaitianli Medicines Co., Ltd.
Recruitment status was:  Enrolling by invitation
First Posted : January 4, 2013
Last Update Posted : April 8, 2016
Sponsor:
Collaborator:
Huazhong University of Science and Technology
Information provided by (Responsible Party):
Qidong Gaitianli Medicines Co., Ltd

Study Description
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Brief Summary:
To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.

Condition or disease Intervention/treatment Phase
Hepatic Carcinoma Drug: Huaier Granule Phase 4

Detailed Description:
A Prospective, Multicenter, Open-labeled, Parallel -controlled Clinical Study, to evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Open-labeled, Parallel -Controlled Clinical Study Investigating Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy
Study Start Date : August 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Test group
Test group: Adjuvant therapy + Huaier Granule group.Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 144 weeks after surgery or until study termination Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment
 Drug: Huaier Granule
Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..
No Intervention: Control group: adjuvant therapy
Control group: adjuvant therapy Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Time to significant progression after surgery [ Time Frame: 3 years ]
    Time to significant progression after surgery, including recurrence of local tumor, intrahepatic and extrahepatic metastasis, etc; and to evaluation of postoperative survival period.


Secondary Outcome Measures :
  1. ECOG and QLQ-C30 scores [ Time Frame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]
    On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, assess the scores of Eastern Cooperative Oncology Group(ECOG) and quality of life questionnaire(QLQ)-C30 scale.

  2. Iconography assessment [ Time Frame: Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]
    On week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, give examination of B ultrasonic for Liver, X-ray for chest. If there is a suspected recurrence or metastases, will give enhancement CT/MRI examination for liver and chest; if no recurrence or metastases, will at least give enhancement CT/MRI examination for liver and chest every year.

  3. Alpha-fetoprotein quantitation and related biochemical indicators [ Time Frame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]
    On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, monitor Alpha-fetoprotein quantitation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: ≥ 18 and ≤ 75 years, both male and female;
  2. Non-radical hepatectomy has been performed for hepatocellular carcinoma;
  3. The hepatocellular carcinoma has been confirmed by pathological examination;
  4. The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase(AST), glutamic-oxalacetic transaminase(ALT)<3 upper limit of normal(ULN), total bilirubin ≤2 ULN, serum creatinine <1.5 ULN;
  5. Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): Hb≥9g/dl, platelet count≥60×109/L, neutrophil count> 2.5×109/L;
  6. The expected survival time ≥12 weeks;
  7. The subjects volunteer to sign the informed consent.

Exclusion Criteria:

  1. Non-hepatocellular carcinoma patients;
  2. Those who received radical hepatectomy;
  3. Those with hepatic decompensation;
  4. Pregnant or lactating women;
  5. Those with HIV infection or AIDS-associated diseases;
  6. Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency;
  7. Those who can not take drugs by oral route; or those develop serious adverse drug reaction;
  8. Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
  9. Conditions that are considered not suitable for this study investigators.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760616


Locations
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China, Hubei
Tongji Hospital Affiliated to Tongji Medical College, Huazhong
Wuhan, Hubei, China
Sponsors and Collaborators
Qidong Gaitianli Medicines Co., Ltd
Huazhong University of Science and Technology
Investigators
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Principal Investigator: Xiaoping Chen, Professor Huazhong University of Science and Technology
More Information
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Responsible Party: Qidong Gaitianli Medicines Co., Ltd
ClinicalTrials.gov Identifier: NCT01760616     History of Changes
Other Study ID Numbers: HE-201102
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Qidong Gaitianli Medicines Co., Ltd:
Huaier Granule;
After non-radical hepatectomy;
Prevention of Disease Progression of Hepatocarcinoma;
Safety.
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Disease Progression
Disease Attributes
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases